Doxycycline Hyclate

Product NDC: 62332-352
11-digit product format: 623320352
Labeler code: 62332
Product ID: 62332-352_9d36c4e4-75df-42af-bd04-37ccfe7664a7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxycycline Hyclate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Alembic Pharmaceuticals Inc.
Application: ANDA210537
Marketing category: ANDA
Marketing start: 2020-03-05
Substance: DOXYCYCLINE HYCLATE
Active strength: 20 mg/1
Pharmacologic classes: Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A210537-001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB		2020-03-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A210537-001	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A210537-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-03-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210537-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-03-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210537-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-03-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210537-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-03-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210537-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-03-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210537-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-03-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210537-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-03-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210537-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-03-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210537-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-03-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210537-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-03-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210537-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-03-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210537-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-03-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210537-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-03-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210537-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-03-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210537-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-03-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210537-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-03-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210537-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-03-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210537-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-03-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210537-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-03-03	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210537-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-03-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210537-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-03-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210537-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-03-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210537-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-03-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210537-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-03-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210537-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-03-03	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210537-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-03-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210537-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-03-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210537-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-03-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210537-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-03-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210537-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-03-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210537-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-03-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210537-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-03-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210537-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-03-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210537-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-03-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210537-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-03-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210537-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-03-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210537-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-03-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210537-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-03-03	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210537-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2020-03-03	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A210537-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210537-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210537-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210537-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210537-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210537-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210537-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210537-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210537-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210537-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210537-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210537-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210537-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210537-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210537-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210537-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210537-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210537-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210537-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210537-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210537-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210537-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210537-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210537-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210537-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210537-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210537-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210537-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210537-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210537-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210537-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210537-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210537-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210537-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210537-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210537-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210537-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210537-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210537-001	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Doxycycline Hyclate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DOXYCYCLINE HYCLATE	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
19XTS3T51U	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
283535	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7c33c1b8-100e-4df8-be8d-de3eed7ced94	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b4321c75-2e87-4d90-9726-9a28fb2293a3	Product name	3	20260112
5e99724e-0654-4aec-b7a2-0b9b10e312ee	Product name	3	20250227
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
d2d36660-68ce-7e7d-0630-ec4b0d859fad	Product name	6	20220921
a239f4dd-cf93-4660-b190-f97d000f249f	Product name	7	20210607
a9d03566-caeb-4466-8021-74599b048880	Product name	3	20210604
12750814-20f7-4f35-b5fa-dbc8811ba858	Product name	9	20201007
00a5dbaa-1b7d-4e56-be0c-fedc7bbf5ade	Product name	1	20200706
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7b4b06ac-8c50-45f0-9556-293ea558a294	Product name	1	20180808
6a5b4392-5ab0-af0d-e0be-47b34e9dbb84	Product name	5	20171121
01a4aa74-7e05-63bd-bc10-1b5ceb111371	Product name	2	20171115
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
58b1278c-6dce-49b6-a05e-ea16f389acba	Product name	1	20160620
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
62332-352-31	Doxycycline Hyclate	100 in 1 BOTTLE	TABLET, FILM COATED	100	9
62332-352-60	Doxycycline Hyclate	60 in 1 BOTTLE	TABLET, FILM COATED	60	9
62332-352-91	Doxycycline Hyclate	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62332-352	DOXYCYCLINE HYCLATE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS INC.]	8	Current NDC, Legacy NDC, 3 package rows	20250116_7c33c1b8-100e-4df8-be8d-de3eed7ced94.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Alembic Pharmaceuticals Inc.	7c33c1b8-100e-4df8-be8d-de3eed7ced94	2025-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210537 application number: ANDA210537 ndc (product): 62332-352
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Alembic Pharmaceuticals Limited	ec4535a1-69f0-40a2-bcba-11afc75c721d	2023-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210537 application number: ANDA210537

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
19XTS3T51U	DOXYCYCLINE HYCLATE	24390-14-5	DOXYCYCLINE HYCLATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
283535	doxycycline hyclate 20 MG Oral Tablet	PSN	7c33c1b8-100e-4df8-be8d-de3eed7ced94	9
283535	doxycycline hyclate 20 MG Oral Tablet	SCD	7c33c1b8-100e-4df8-be8d-de3eed7ced94	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
62332-352-31	62332035231	100 TABLET, FILM COATED in 1 BOTTLE (62332-352-31)	2020-03-05	0000-00-00	No	No	Current
62332-352-60	62332035260	60 TABLET, FILM COATED in 1 BOTTLE (62332-352-60)	2020-03-05	0000-00-00	No	No	Current
62332-352-91	62332035291	1000 TABLET, FILM COATED in 1 BOTTLE (62332-352-91)	2020-03-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Doxycycline Hyclate Tablets, USP Rx Only	Alembic Pharmaceuticals Inc. \| Alembic Pharmaceuticals Limited	2025-04-30	Human Prescription Drug Label	9